Drug company (FDA labeler)
Xiromed, LLC
NDC labeler code: 70700
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 7 products
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 5 products
- ProgesteroneCrinone, Prometrium, Endometrin · 4 products
- FluorouracilFavlyxa, Tolak, Efudex · 4 products
- DeferasiroxJadenu, Deferasorox, Exjade · 3 products
- Estradiol valerateDelestrogen · 3 products
- Testosterone cypionateDepo-Testosterone, Azmiro · 3 products
- OmeprazolePrilosec · 3 products
- Midodrine hydrochloride3 products
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 2 products
- GuanfacineIntuniv · 2 products
- Estradiol and norethindrone acetateLopreeza, Combipatch (Estradiol/Norethindrone Acetate Transdermal System), Etyqa · 2 products
- Norethindrone acetate and ethinyl estradiolJunel 21 Day, Loestrin 21 Day, Fyavolv · 2 products
- LansoprazolePrevacid Solutab, Prevacid · 2 products
- Neostigmine methylsulfateBloxiverz · 2 products
- NorethindroneErrin, Nora Be, Camila · 2 products
- Irinotecan hydrochlorideCamptosar, Onivyde · 2 products
- Fluocinonide1 product
- Ephedrine sulfateEmerphed Pfs, Akovaz, Emerphed · 1 product
- FulvestrantCligavyx, Faslodex · 1 product
- Ganirelix acetateFyremadel · 1 product
- Etonogestrel and ethinyl estradiolNuvaring, Enilloring, Eluryng · 1 product
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
- Methylene blueProvayblue · 1 product
- TestosteroneVogelxo, Natesto Nasal Gel, Testopel · 1 product
- Betamethasone valerate1 product
- KetoconazoleKetodan · 1 product
- AcyclovirZovirax, Avaclyr · 1 product
- RamelteonRozerem · 1 product
- Norethindrone acetateGallifrey · 1 product
- PhytonadioneVitamin K1 · 1 product
- FosfomycinContepo · 1 product
- Medroxyprogesterone acetateProvera, Depo-Provera, Depo-Subq Provera · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 19, 2025 | ANDA218391 | Progesterone PROGESTERONE | Xiromed |
| July 30, 2025 | ANDA219363 | Methylene blue METHYLENE BLUE | Xiromed |
| December 10, 2024 | ANDA217386 | Phytonadione PHYTONADIONE | Gland |
| February 23, 2024 | ANDA218326 | Guanfacine GUANFACINE HYDROCHLORIDE | Xiromed |
| June 29, 2023 | ANDA211157 | Etonogestrel and ethinyl estradiol ENILLORING | Xiromed |
| April 28, 2023 | ANDA216656 | Estradiol valerate ESTRADIOL VALERATE | Xiromed |
| April 18, 2023 | ANDA210639 | Betamethasone valerate BETAMETHASONE VALERATE | Xiromed |
| April 13, 2023 | ANDA215351 | Testosterone cypionate TESTOSTERONE CYPIONATE | Xiromed |
| February 28, 2023 | ANDA215658 | Ganirelix acetate GANIRELIX ACETATE | Gland |
| November 25, 2022 | ANDA216209 | Ramelteon RAMELTEON | Xiromed |
| August 10, 2022 | ANDA211783 | Estradiol ESTRADIOL | Xiromed |
| April 21, 2022 | ANDA215825 | Ephedrine sulfate EPHEDRINE SULFATE | Xiromed |
| January 5, 2022 | ANDA215634 | Progesterone PROGESTERONE | Xiromed |
| August 13, 2021 | ANDA213553 | Fulvestrant FULVESTRANT | Xiromed |
| May 21, 2021 | ANDA213601 | Ketoconazole KETOCONAZOLE | Xiromed |
| May 18, 2021 | ANDA211189 | Tobramycin TOBRAMYCIN SULFATE | Gland |
| March 4, 2021 | ANDA212227 | Glycopyrrolate GLYCOPYRROLATE | Xiromed |
| December 10, 2020 | ANDA212977 | Omeprazole OMEPRAZOLE | Xiromed |
| October 6, 2020 | ANDA212548 | Fosfomycin FOSFOMYCIN TROMETHAMINE | Xiromed |
| October 1, 2020 | ANDA207849 | Midodrine hydrochloride MIDODRINE HYDROCHLORIDE | Xiromed |
| April 16, 2020 | ANDA210835 | Testosterone TESTOSTERONE | Xiromed |
| January 29, 2020 | ANDA201501 | Acyclovir ACYCLOVIR | Xiromed |
| December 30, 2019 | ANDA212995 | Deferasirox DEFERASIROX | Piramal |
| November 26, 2019 | ANDA212976 | Fluocinonide FLUOCINONIDE | Xiromed |
| November 18, 2019 | ANDA212993 | Irinotecan hydrochloride IRINOTECAN HYDROCHLORIDE | Gland |
Show the other 15 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 16, 2019 | ANDA212968 | Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE | Gland |
| September 30, 2019 | ANDA212612 | Glycopyrrolate GLYCOPYRROLATE | Gland |
| October 12, 2018 | ANDA210227 | Medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE | Xiromed |
| June 15, 2018 | ANDA210034 | Clobetasol propionate CLOBETASOL PROPIONATE | Xiromed |
| April 17, 2018 | ANDA209701 | Clobetasol propionate CLOBETASOL PROPIONATE | Xiromed |
| December 26, 2017 | ANDA210124 | Fluorouracil FLUOROURACIL | Gland |
| October 27, 2017 | ANDA210123 | Fluorouracil FLUOROURACIL | Gland |
| October 20, 2017 | ANDA205229 | Progesterone PROGESTERONE | Xiromed |
| February 10, 2017 | ANDA207261 | Estradiol and norethindrone acetate ESTRADIOL AND NORETHINDRONE ACETATE | Xiromed |
| November 10, 2016 | ANDA205278 | Norethindrone acetate NORETHINDRONE ACETATE | Xiromed |
| July 25, 2016 | ANDA203203 | Lansoprazole LANSOPRAZOLE | Xiromed |
| February 19, 2015 | ANDA202770 | Norethindrone acetate and ethinyl estradiol NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Xiromed |
| November 6, 2013 | ANDA202771 | Norethindrone acetate and ethinyl estradiol NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Xiromed |
| June 24, 2013 | ANDA201483 | Norethindrone NORETHINDRONE | Xiromed |
| June 12, 2013 | ANDA200980 | Norethindrone NORETHINDRONE | Xiromed |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026